History appears to be repeating itself to a group of U.S. Food and Drug Administration (FDA) scientists—their concerns about medical device safety have once again been dismissed by the federal government.

The group of nine former and current FDA scientists created a mini firestorm early last year when they accused managers in the Center for Devices and Radiological Health (CDRH) of pressuring them to approve high-tech products despite their concerns about potential harm to patients. In an April 2, 2009, letter to President Barack Obama, the scientists claim FDA managers violated laws, rules and regulations; suppressed or altered scientific or technological findings and conclusions; abused their power and authority; and engaged in illegal retaliation against whistleblowers.

The letter cited numerous cases of malfeasance. Some of the most serious allegations were lobbed against former CDRH Director Daniel Schultz (who resigned amid the brouhaha) and Office of Device Evaluation Director Donna-Bea Tillman, among others. Tillman, the scientists claim, ignored the recommendations of FDA experts and approved a medical device to protect breast cancer—after reportedly receiving a phone call from Connecticut Congressman Christopher Shays. Schultz, meanwhile, allegedly approved a medical device against the unanimous opinion (and objections) of more than 20 FDA scientists, medical officers and managers, the letter stated. A New York Times article claimed the approval was the first in agency history to ignore unanimous opposition from staff scientists and administrators.

The scientists’ letter also accused FDA officials of buckling to intense lobbying efforts by ReGen Biologics Inc. for 510(k) approval of its Menaflex knee implant and giving the company preferential treatment despite objections by experts. The scientists’ concerns were validated in October when FDA officials—in a rare move—admitted making a mistake in approving the Menaflex implant. “There were in fact numerous departures from the review process,” CDRH Director Dr. Jeffrey Shuren said about the agency’s 2008 decision. “There is no adequate information in the record establishing why the device was approved.”

The 510(k) process—popular with manufacturers for its simple, less stringent device clearance requirements (detailed product testing is not mandatory)—was partly responsible for prompting federal health department inspectors to reopen an investigation into the scientists’ 2009 allegations. Those accusations were dismissed in February by the Inspector General’s Office (IG) within the U.S. Department of Health and Human Services, which concluded there was no criminal behavior in the FDA managers’ actions or decisions.

However, the IG reopened its investigation in September, citing the seriousness of the scientists’ accusations. The IG’s decision to reopen the case also may have been influenced by a meeting with the Project on Government Oversight (POGO), a Washington, D.C.-based watchdog group that conducted its own investigation of the whistleblowers’ complaints. The IG and POGO representatives met over the summer.

Gerald Roy, deputy inspector general for investigations, told The Wall Street Journal that the new investigation was based upon “a responsibility to make sure FDA divisions are functional.” To ensure such functionality, the IG focused on two areas of the CDRH: its 510(k) clearance process and its procedures for resolving internal scientific and administrative disputes.

Many of the whistleblowers’ original allegations revolved around the FDA’s product approval process. Besides questioning the Menaflex okay, the scientists also disagreed with their superiors about radiological devices such as computed tomography (CT) scanners, magnetic resonance imaging machines and mammogram machines. Though they detect diseases, the scientists claim these machines also expose patients to unnecessarily high doses of radiation.

In the last year, hundreds of radiation overdoses have been reported with imaging devices, particularly CT scanners, which are used by hospitals nationwide. The whistleblowers have argued that these problems underscore the concerns they raised about such devices.

But in an announcement earlier this month, the FDA said that CT scanners are safe when used properly. After more than a year of investigation, the agency claimed, the overdoses most likely resulted from improper use by imaging technicians.

Within days of the FDA’s announcement, the IG once again dismissed the scientists’ complaints. And, once again, the scientists cried foul, saying the IG’s second investigation was a farce. One of the whistleblowers—who claims his contract at the FDA was cancelled after he filed a complaint—accused the IG office of dismissing the case without even interviewing any of the scientists.

“It’s hard for me to believe this was a bona fide investigation when they haven’t even contacted the people who reported these violations,” Dr. Julian Nicholas, an Oxford-trained intestinal specialist, told The Associated Press. “Such a huge amount of money is at stake and so many people are affected that for the [Office of Inspector General] not to conduct a credible investigation is criminal in itself.”

The FDA’s device leadership team shared the results of the latest investigation with employees, according to a Nov. 5 e-mail obtained by The Associated Press.

The e-mail was written by Shuren and was sent to members of his staff. He said the investigation found no evidence of retaliation against the accusers nor “material violation of rules with respect to documenting significant decisions.”

Shuren noted in his e-mail that the FDA hired a private contractor last spring to review the device unit’s structure and make recommendations for improving relations between scientists and management. The contractor recommended changes in internal communications and training opportunities, Shuren said.